FDA 510(k) Application Details - K172889

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K172889
Device Name	Thermometer, Electronic, Clinical
Applicant	Shenzhen Pacom Medical Instruments Co., Ltd. 8 Floor, B District, B Building, No. 5 Industry five road, Jianbian Community, Songgang Shenzhen 518105 CN Other 510(k) Applications for this Company
Contact	Liangzhou Zhong Other 510(k) Applications for this Contact
Regulation Number	880.2910   More FDA Info for this Regulation Number
Classification Product Code	FLL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/21/2017
Decision Date	05/25/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review